Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App

Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)

This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Malignant Skin Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow. II. Gather preliminary data on the number of patients who develop Grade 3 + 4 immune-related adverse event (irAE) or require ER visit within 100 days of registration and treatment with IPI/NIVO.

OUTLINE: This is an observational study.

Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Renee Bradshaw; Phone Number: 507-284-2511

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Svetomir N. Markovic, MD, PhD
      • Contact: Renee Bradshaw; Phone Number: 507-284-2511
      • Principal Investigator: Lisa A. Kottschade, APRN, CNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with the diagnosis of skin cancer/melanoma undergoing dual ICI therapy with ipilimumab/nivolumab (IPI/Nivo) as part of regular clinical practice.

Description

Inclusion Criteria:

• Any skin cancer/melanoma patient starting dual [ipilimumab/nivolumab (IPI/NIVO)] immune checkpoint inhibitor (ICI) therapy

Exclusion Criteria:

• Does not meet inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational; Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.

Other: Non-Interventional Study; Non-Interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 3-4 IR-adverse events	Will be assessed by the number of patients who experience at least one grade 3-4 Immune-Related Adverse Events (IR-AE) within 100 days of treatment with ipilimumab/nivolumab (IPI/NIVO). Events will be self-reported using the VIGILANT app, which is being developed to help manage adverse events after treatment.	Up to 100 days following treatment with IPI/NIVO

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Svetomir N. Markovic, MD, PhD, Mayo Clinic; Principal Investigator: Lisa A. Kottschade, APRN, CNP, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin and Connective Tissue Diseases; Melanoma; Skin Neoplasms
• Other Study ID Numbers: 23-011475 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-09081 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No